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News Breaks
January 30, 2013
08:24 EDTPFEPfizer CEO hints at potential future split of core drugs unit, FT says
Pfizer (PFE) CEO Ian Read said the company has no immediate plans to restructure further, but suggested the pharma industry will globally separate into models with an "innovative core" and a "value core" and Reed sees "management moving to manage the business that way over time,” reported Financial Times. Reed added that the company is "open to any construct that produces value for Pfizer” shareholders. Reference Link
News For PFE From The Last 14 Days
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May 21, 2013
07:16 EDTPFEPfizer management to meet with Leerink
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May 20, 2013
17:04 EDTPFEPfizer discontinues phase 3 study of inotuzumab ozogamicin
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May 16, 2013
08:55 EDTPFEBofA/Merrill's pharmaceuticals analysts hold analyst/industry conference call
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May 10, 2013
16:29 EDTPFEOn The Fly: Closing Wrap
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12:31 EDTPFEOn The Fly: Midday Wrap
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11:48 EDTPFEDrugmakers to face pressure on U.S. prices, Reuters says
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09:21 EDTPFEOn The Fly: Pre-market Movers
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08:08 EDTPFEPain Therapeutics discloses Pfizer reassessing continued Remoxy partnership
Pain Therapeutics (PTIE) disclosed a letter its CEO was sent from partner Pfizer (PFE) in which the drug maker said it is reassessing its endorsement of the Remoxy program "given the years of delay, additional cost incurred to bring the program to this point and development work left in the program." Pfizer said it will be reaching out to Pain Therapeutics "shortly" to have a confidential discussion about the terms of the companies' contractual agreement over the pain drug. Pfizer that it appears there is a regulatory pathway forward for Remoxy, but that the company does not expect to respond to submit a Complete Response letter for Remoxy to the FDA before mid-2015. Pfizer added in its letter to Pain Therapeutics "no final decision has been made at this time" on how it will proceed with the Remoxy development program. Shares of Pain Therapeutics fell 47% to $2.81 in pre-market trading following the disclosure of the correspondence.
07:46 EDTPFEDURECT says additional clinical studies needed for Remoxy
DURECT (DRRX) announced that Pfizer (PFE) has provided an update on Remoxy in a regulatory filing. Pfizer's disclosure included: "We have been working to address the issues raised in the letter, which primarily relate to manufacturing. We met with the FDA in March 2013 to discuss our plan to address the June 2011 "complete response" letter. We received written guidance from the FDA in May regarding required next steps, including additional clinical studies, to address the letter. Based on this guidance, we are considering our options with respect to Remoxy. If we elect to continue development of Remoxy, we would not expect to submit a response to the 'complete response' letter before mid-2015." DURECT said it understands from Pfizer that additional clinical studies are necessary and include, in part, a pivotal bioequivalence study with the modified formulation to bridge to the clinical data conducted with the original formulation, as well as an abuse potential study with the modified Remoxy formulation. Remoxy is based on DURECT's ORADUR technology. Shares of Pfizer's Remoxy partner Pain Therapeutics (PTIE) are down 56% in pre-market trading, while shares of DURECT are down 13%, or 20c, to $1.39.
May 9, 2013
10:17 EDTPFEShire trades higher in London amid takeover chatter, Guardian says
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May 8, 2013
10:33 EDTPFEBristol-Myers, Pfizer announced results from ARISTOTLE trial subanalysis
Bristol-Myers (BMY) and Pfizer (PFE) announced yesterday that results from a prespecified subanalysis of the ARISTOTLE trial were published in Circulation, the peer-reviewed journal of the American Heart Association. Results from the subanalysis showed that the reductions in stroke or systemic embolism, number of major bleeding events and mortality demonstrated with Eliquis compared to warfarin in the ARISTOTLE trial were consistent across subgroups defined based on levels of International Normalized Ratio control in patients with nonvalvular atrial fibrillation. This story corrects a headline from yesterday.

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